PROJECT SUMMARY ? EPIDEMIOLOGY AND CLINICAL RESEARCH INFORMATICS SHARED RESOURCE The Epidemiology and Clinical Research Informatics Shared Resource (ECRISR) serves a crucial dual role in support of both epidemiological and clinical trial research management by providing overall research management expertise and informatics-based management solutions to AECC investigators. The ECRISR has extensive experience supporting all aspects of epidemiological research with a special focus on the development of Study Management Informatics Systems (SMIS) which facilitate the diverse management, data and operational aspects of implementing complex study protocols. The SMIS incorporate automated workflow processes across shared facilities, implement QA and best practices to ensure data integrity, automate data integration from various sources, and establish real-time data monitoring in order to provide efficient research operations, improved data access and progress/regulatory reporting. The SMIS integrate with internal and external EHR and laboratory systems, and support management of multi-center clinical research projects. The ECRISR is responsible for the development, implementation and on-going oversight of a comprehensive clinical trial and research management program to standardize and streamline all AECC clinical trial and research process management. The resource has extensively customized the functionality of the Velos CTRMS to provide QA oversight and facilitate compliance/monitoring of all clinical trial activity. The ECRISR has established workflows, policies and procedures that collaboratively engage, guide and/or provide oversight to other shared resources involved in cancer research. The research management process spans the lifecycle of protocol management from IRB submission to completion and the ECRISR continually expands the purview of the program with the design of custom interfaces between the CTRMS, EPIC and multiple IRB institutional systems to provide fully integrated regulatory and operational management of clinical trials. The ECRISR provides competency and capacity to develop scalable and robust informatics infrastructure which leverage big-data analytic resources to enable a wide spectrum of research across the enterprise. The facility maintains a sophisticated applications framework with data governance and security protocols in compliance with national standards and provides interoperability with other systems to create patient-centered, integrative informatics platforms for comparative effectiveness and preventive care research. The resource participates in national informatics initiatives, develops innovative informatics approaches, provides novel solutions in the realm of data extraction and Quality Assurance. The ECRISR strives to foster interdisciplinary collaboration, serves as a data coordinating center, provides data management services, assists in the development of pilot and grant proposals, and works closely with biostatisticians in the production of complex databases and publications.